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Intravitreal Bevacizumab Vs Photocoagulation for Proliferative Diabetic Retinopathy
This study is currently recruiting participants.
Verified by Asociación para Evitar la Ceguera en México, June 2006
Sponsored by: Asociación para Evitar la Ceguera en México
Information provided by: Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier: NCT00347698
  Purpose

The purpose of the study is to evaluate the safety and efficacy of 2.5 mg of intravitreal bevacizumab in one eye, versus panretinal photocoagulation in the contralateral eye, for the treatment of patients with untreated symmetric proliferative diabetic retinopathy.


Condition Intervention Phase
Diabetic Retinopathy
Drug: intravitreal injection of bevacizumab
Procedure: panretinal photocoagulation
Phase II
Phase III

MedlinePlus related topics: Diabetic Eye Problems Retinal Disorders
Drug Information available for: Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Intravitreal Bevacizumab Vs Panretinal Photocoagulation for the Treatment of Proliferative Diabetic Retinopathy: A One-Year Prospective, Contralateral Eye Study

Further study details as provided by Asociación para Evitar la Ceguera en México:

Primary Outcome Measures:
  • Best corrected visual acuity at six months and one year
  • Macular thickness measured by OCT at six months and one year
  • Median deviation in visual fields at one year
  • Score on a patient satisfaction scale at six months and one year

Secondary Outcome Measures:
  • Complications associated to each treatment

Estimated Enrollment: 30
Study Start Date: March 2006
Estimated Study Completion Date: August 2007
Detailed Description:

The current gold standard for the treatment of proliferative diabetic retinopathy is panretinal photocoagulation. However, it is a treatment that results in significant discomfort to the patient, causes reduction of visual acuity and visual field impairment. Intravitreal bevacizumab is a novel treatment that reduces intraocular VEGF concentration and therefore inhibits neovascular proliferation, without causing significant disconfort to the patient, nor affecting visual acuity or visual fields (although with other risks associated with intravitreal injection). Making a comparison between both treatments in different patients is difficult because there are other variables that influence the progression of the disease (such as glycemic control or renal insufficiency). Therefore this study is designed using both treatments in the same patient: intravitreal bevacizumab in one eye, compared to panretinal photocoagulation in the contralateral eye, and evaluating visual acuity, visual fields, fluorescein angiography, optic coherence tomography of the macula, and patient discomfort, in a one-year follow-up.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • symmetric proliferative diabetic retinopathy without high risk characteristics
  • age 18 years or older
  • patient consent

Exclusion Criteria:

  • heart attack or cerebrovascular attack
  • only eye
  • retinal detachment
  • vitreous haemorrhage
  • previous treatment for diabetic retinopathy
  • media opacities that preclude visualization of the fundus
  • pregnancy
  • inability to understands the implications of the protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347698

Contacts
Contact: Gerardo García-Aguirre, MD +52 (55) 10841400 ext 1172 retinamex@yahoo.com
Contact: Elizabeth Reyna-Castelán, MD +52 (55)10841400 ext 1172 retinamex@yahoo.com

Locations
Mexico, D. F
Asociación para Evitar la Ceguera en México Recruiting
Mexico City, D. F, Mexico, 04030
Contact: Yoko Burgoa     +52 (55) 1084 1400 ext 1171     retinamex@yahoo.com    
Contact: Mariana Martinez, MD     +52 (55) 1084 1400 ext 1171     retinamex@yahoo.com    
Principal Investigator: Gerardo García-Aguirre, MD            
Sub-Investigator: Hugo Quiroz-Mercado, MD            
Sub-Investigator: Veronica Kon-Jara, MD            
Sub-Investigator: Mitzy Torres, MD            
Sub-Investigator: Elizabeth Reyna-Castelan, MD            
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Principal Investigator: Gerardo García-Aguirre, MD Asociación para Evitar la Ceguera en México
  More Information

Publications:
[No authors listed] Treatment techniques and clinical guidelines for photocoagulation of diabetic macular edema. Early Treatment Diabetic Retinopathy Study Report Number 2. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1987 Jul;94(7):761-74.
Frank RN. Visual fields and electroretinography following extensive photocoagulation. Arch Ophthalmol. 1975 Aug;93(8):591-8.
Salti H. Visual dysfunction after panretinal photocoagulation in patients with severe diabetic retinopathy and good vision. Am J Ophthalmol. 2006 Feb;141(2):422; author reply 422-3. No abstract available.
Witmer AN, Vrensen GF, Van Noorden CJ, Schlingemann RO. Vascular endothelial growth factors and angiogenesis in eye disease. Prog Retin Eye Res. 2003 Jan;22(1):1-29. Review.
Presta LG, Chen H, O'Connor SJ, Chisholm V, Meng YG, Krummen L, Winkler M, Ferrara N. Humanization of an anti-vascular endothelial growth factor monoclonal antibody for the therapy of solid tumors and other disorders. Cancer Res. 1997 Oct 15;57(20):4593-9.
Spaide RF, Fisher YL. Intravitreal bevacizumab (Avastin) treatment of proliferative diabetic retinopathy complicated by vitreous hemorrhage. Retina. 2006 Mar;26(3):275-8.
Avery RL. Regression of retinal and iris neovascularization after intravitreal bevacizumab (Avastin) treatment. Retina. 2006 Mar;26(3):352-4. No abstract available.
Iturralde D, Spaide RF, Meyerle CB, Klancnik JM, Yannuzzi LA, Fisher YL, Sorenson J, Slakter JS, Freund KB, Cooney M, Fine HF. Intravitreal bevacizumab (Avastin) treatment of macular edema in central retinal vein occlusion: a short-term study. Retina. 2006 Mar;26(3):279-84.
Rosenfeld PJ, Moshfeghi AA, Puliafito CA. Optical coherence tomography findings after an intravitreal injection of bevacizumab (avastin) for neovascular age-related macular degeneration. Ophthalmic Surg Lasers Imaging. 2005 Jul-Aug;36(4):331-5.
Rosenfeld PJ, Fung AE, Puliafito CA. Optical coherence tomography findings after an intravitreal injection of bevacizumab (avastin) for macular edema from central retinal vein occlusion. Ophthalmic Surg Lasers Imaging. 2005 Jul-Aug;36(4):336-9.

Study ID Numbers: APEC-007
Study First Received: June 30, 2006
Last Updated: June 30, 2006
ClinicalTrials.gov Identifier: NCT00347698  
Health Authority: Mexico: Ethics Committee;   Mexico: Ministry of Health

Keywords provided by Asociación para Evitar la Ceguera en México:
diabetic retinopathy
bevacizumab
photocoagulation

Study placed in the following topic categories:
Diabetic Retinopathy
Eye Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Bevacizumab
Endocrinopathy
Diabetes Complications
Retinal Diseases
Diabetic Angiopathies

Additional relevant MeSH terms:
Antineoplastic Agents
Therapeutic Uses
Growth Substances
Physiological Effects of Drugs
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009